Outcome of Lipitaezar tablets in Non-Alcoholic Fatty Liver changes

Effect of Lipitaezar tablets, a proprietary formulation in patients suffering from Non-alcoholic fatty liver disease (NAFLD): an open label, randomized, controlled clinical study - Not Applicable

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054391

Enrollment

Registered

2023-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Individuals of either sex between the age group of 30 - 60 years 2.Individuals with BMI = 23.5 kg/m2- = 35 kg/m2 3.Individuals with presence of NAFLD grade II or above on Ultrasound 4.Individuals willing to abide by the study related procedures

Exclusion criteria

Exclusion criteria: 1.Individuals with secondary obesity e.g. Prader-Willi syndrome, Corticosteroid induced obesity, or other endocrine disorders 2.Individuals with alcohol addiction 3.Individuals with viral hepatitis disorders (Hepatitis B, Hepatitis C) 4.Individuals with known history of usage of herbal medications/ nutritional supplements/ multivitamin supplements/ pre and probiotic supplementation within past 30 days for any indication 5.Pregnant or lactating females

Design outcomes

Primary

Measure	Time frame
1. Number of participants showing improvement in fatty liver changes 10% more in Lipitaezar tablets group compared to Vitamin E group 2. 5% more improvement in insulin resistance due to Lipitaezar tablets in comparison with Vitamin ETimepoint: Day 0, Day 90	—

Secondary

Measure	Time frame
5% more improvement in the anthropometry due to Lipitaezar tablets in comparison with Vitamin ETimepoint: Day 0, Day 30, Day 60, Day 90	—

Countries

India

Contacts

Public ContactDr Revati Bhat

Interactive Research School for Health Affairs Bharati Vidyapeeth (Deemed to be) University

supriya.bhalerao@bharatividyapeeth.edu9527589516

Outcome results